Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Dimethylaminoethanol

INCI: DIMETHYL MEA

CAS Number
108-01-0
Function
pH Regulator, Buffering Agent
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 2.5%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No specific FDA monograph or restriction for cosmetic use. Under MoCRA, remains permissible without specific concentration limits; manufacturer bears responsibility for safety substantiation.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for Dimethylaminoethanol. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL 150 mg/kg bw/day oral rat oral REACH
NOAEL >7 mg/kg bw/day oral mouse oral REACH
NOAEL >240 mg/kg bw/day oral rat oral REACH

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Short-term Exposure Effects
The substance is severely irritating to the respiratory tract. The substance is corrosive to the eyes and skin. Corrosive on ingestion. Inhalation of the vapour may cause lung oedema. See Notes. The effects may be delayed. Medical observation is indicated.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its vapour, through the skin and by ingestion.

Expert Verdict

DMAE is an EU Annex III restricted substance (max 2.5% leave-on) due to its trialkylamine classification, with mandatory nitrosamine controls. Margin of safety calculations fall substantially below the SCCS threshold of 100 at the permitted limit, raising substantive safety concerns for leave-on applications.

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Concern Level: Moderate

Regulatory Flags

eu-annex-iii-restricted nitrosamine-risk mos-below-threshold vacuolar-cytopathology no-sccs-opinion no-dermal-absorption-data mattilsynet-reviewed fda_food_additive

Frequently Asked Questions

Is Dimethylaminoethanol safe in cosmetics?

DMAE is an EU Annex III restricted substance (max 2.5% leave-on) due to its trialkylamine classification, with mandatory nitrosamine controls. Margin of safety calculations fall substantially below the SCCS threshold of 100 at the permitted limit, raising substantive safety concerns for leave-on applications. The EU classifies Dimethylaminoethanol as "restricted". Safety rating: MODERATE. 3 toxicological study endpoint(s) are available in our database.

Is Dimethylaminoethanol allowed in the EU?

Dimethylaminoethanol EU regulatory status: restricted. Maximum allowed concentration: 2.5%. This is based on EU Regulation 1223/2009 and its amendments.

What does Dimethylaminoethanol do in cosmetics?

Dimethylaminoethanol functions as: pH Regulator, Buffering Agent. It is classified as a cosmetic ingredient in our database. CAS number: 108-01-0.

What is the Margin of Safety for Dimethylaminoethanol?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Dimethylaminoethanol?

The NOAEL (No Observed Adverse Effect Level) for Dimethylaminoethanol is 150 mg/kg bw/day based on a oral study via oral route in rat. A total of 3 study endpoints are available. Source: REACH.

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